The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for Dardik Carotid Shunt.
| Device ID | K001621 |
| 510k Number | K001621 |
| Device Name: | DARDIK CAROTID SHUNT |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | VASCUTECH, INC. 164 MIDDLESEX TURNPIKE Burlington, MA 01803 |
| Contact | Trent G Kamke |
| Correspondent | Trent G Kamke VASCUTECH, INC. 164 MIDDLESEX TURNPIKE Burlington, MA 01803 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-26 |
| Decision Date | 2000-12-06 |